Table 7.
Adverse events reported in at least 5% of the subjects in any treatment group (safety-analysis population)
| System organ class
|
Placebo (n = 186) | BUP150 (n = 190) | BUP300 (n = 189) |
|---|---|---|---|
| Preferred term | |||
| n (%) of subjects with any AE | 103 (55) | 106 (56) | 123 (65) |
| Gastrointestinal disorders | 39 (21) | 47 (25) | 63 (33) |
| Dry mouth | 8 (4) | 12 (6) | 28 (15) |
| Nausea | 15 (8) | 13 (7) | 16 (8) |
| Constipation | 3 (2) | 8 (4) | 11 (6) |
| Infections and infestations | 42 (23) | 28 (15) | 35 (19) |
| Nasopharyngitis | 35 (19) | 26 (14) | 29 (15) |
| Nervous system disorders | 29 (16) | 29 (15) | 37 (20) |
| Headache | 13 (7) | 16 (8) | 19 (10) |
| Tremor | 0 | 4 (2) | 9 (5) |
| Psychiatric disorders | 14 (8) | 9 (5) | 18 (10) |
| Insomnia | 6 (3) | 0 | 10 (5) |
Abbreviations: AE, adverse event; BUP150, bupropion SR 150 mg/day (once daily); BUP300, bupropion SR 150 mg/day (twice daily); n, number.